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Metabolic Modulators

SS-31 (Elamipretide)

Mitochondria-targeted peptide that stabilizes cardiolipin in the inner membrane; FDA-approved for Barth syndrome, experimental elsewhere.

FDA approvedEvidence level 4 of 5: Human RCTs or approved abroadAlso: Elamipretide, Forzinity, MTP-131, Bendavia

Overview

SS-31 (elamipretide) is a four-amino-acid peptide that crosses cell membranes and concentrates in the inner mitochondrial membrane. There it binds cardiolipin, a lipid that holds the energy-producing machinery together, stabilizing electron transport, improving ATP production and reducing oxidative stress. In September 2025 it became the first FDA-approved treatment for Barth syndrome, a rare inherited cardiolipin disorder, under accelerated approval based on muscle-strength improvement. Larger trials in other conditions — mitochondrial myopathy, heart failure, dry macular degeneration — did not meet their main goals. Its use for general aging remains experimental, and daily injections commonly cause injection-site reactions.

Classification
Synthetic mitochondria-targeted tetrapeptide (D-Arg-Dmt-Lys-Phe-NH2)
Route
Subcutaneous
Half-life
Short (hours); peak 0.5–1 hour after SC dose

Mechanism of action

Primary targetCardiolipin in the inner mitochondrial membrane
  1. Enters mitochondriaCell-permeable peptide accumulates at the inner mitochondrial membrane.
  2. Binds cardiolipinStabilizes cardiolipin and the cristae structure it supports.
  3. Electron transport stabilizedImproves supercomplex function and electron flow to oxygen.
  4. Less oxidative stressReduces electron leak and reactive oxygen species production.
  5. ATP output restoredImproved energy production in stressed or diseased cells.
Downstream effects
  • Improved muscle strength (Barth)
  • Better mitochondrial efficiency
  • Reduced oxidative stress

Researched for

  • Barth syndrome (approved)
  • Primary mitochondrial myopathy
  • Heart failure
  • Dry age-related macular degeneration
  • Age-related mitochondrial dysfunction

Research notes

  • TAZPOWER (Barth syndrome, n=12) and its open-label extension supported accelerated approval via knee-extensor strength gains.
  • MMPOWER-3 phase 3 in primary mitochondrial myopathy did not meet its primary endpoints.
  • Phase 2 trials in heart failure and dry AMD (ReCLAIM-2) missed primary endpoints, with some secondary signals.
  • Injection-site reactions occurred in nearly all treated patients; eosinophil increases were seen with longer exposure.

Reported side effects

  • Injection-site redness, itching or pain (very common)
  • Eosinophilia
  • Hypersensitivity reactions (rare, serious)
  • Headache
  • Dizziness

Contraindications & cautions

  • Hypersensitivity to elamipretide
  • Severe renal impairment (dose reduction required)
  • Pregnancy or breastfeeding (limited data)

Lab monitoring

  • CBC with differential (eosinophils)
  • Kidney function (eGFR)
  • CMP
  • Functional/strength testing

Dosing and pricing for SS-31 (Elamipretide)

Dosing references and compound pricing are available to established patients in the secure portal after a medical evaluation.

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